Hologic's Aptima Genitalium Assay Gets Clinically Verified
Zacks Investment Research | Nov 11, 2019 09:37PM ET
Hologic’s (NASDAQ:HOLX) Aptima Mycoplasma genitalium assay recently attained significant recognition based on a positive study outcome. A prospective, multi-center Aptima Mycoplasma genitalium Evaluation Study (AMES) has become the first clinical research to approve the performance of Aptima Mycoplasma genitalium assay in the United States.
For investors’ note, Hologic’s Aptima Mycoplasma genitalium assay is the first-of-its-kind, FDA-approved assay which can be used to diagnose the sexually-transmitted bacterium Mycoplasma genitalium (M. genitalium).
The AMES study result is anticipated to be a major stride forward in the company’s commitment toward strengthening its Diagnostic Solutions business.
More About the Study
The clinical study assessed the prevalence, sensitivity, specificity, positive predictive value, and negative predictive value for the Aptima assay compared to a composite molecular reference standard.
The study assessed 3,300 sexually active women and men between the ages of 15 and 82, at 21 sites across the United States. The M. genitalium incidence rate was found to be 10.1% in women and 10.6% in men. In symptomatic women and men, the prevalence was found to be 11.6% and 12%, respectively. The prevalence was 7.9% and 8.8%, in asymptomatic women and men, respectively.
Hence, the AMES study proves that the incidence rate of M. genitalium was high in both symptomatic and asymptomatic women and men. This is why accurate diagnostic tests, such as the Aptima Mycoplasma genitalium assay, are instrumental in accurately identifying and treating specific bacterial infections.
Results showed that for each of the seven specimen types, Aptima assay results were closely in line with the results attained with the composite reference standard.
According to Hologic, these study results will enable clinicians to choose the specimen type most suited for their patients. Moreover, the availability and clinically-proved efficacy of the Aptima Mycoplasma genitalium assay suggests that validation of laboratory-developed tests for detection of the organism would no longer be necessary.
Market Prospects
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